Advanced HER2-Expressing Solid Tumors.
Conditions
Brief summary
Incidence of AEs and SAEs graded according to NCI CTCAE v5.0, Incidence and nature of DLTs within a 3 + 3 design, The occurrence of DLTs
Detailed description
Pharmacokinetic variables may include: • Cmax • Cmin • AUC0-t • AUC0-inf • CL • Vz • t½, ORR using RECIST v1.1 • DCR of confirmed CR, confirmed PR, or stable disease (SD) lasting 24 weeks (- 7 days) or more weeks following the initiation of BDC-1001 • DoR • PFS, Incidence of ADAs against BDC-1001
Interventions
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
DRUGBDC-1001
Sponsors
Bolt Biotherapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of AEs and SAEs graded according to NCI CTCAE v5.0, Incidence and nature of DLTs within a 3 + 3 design, The occurrence of DLTs | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic variables may include: • Cmax • Cmin • AUC0-t • AUC0-inf • CL • Vz • t½, ORR using RECIST v1.1 • DCR of confirmed CR, confirmed PR, or stable disease (SD) lasting 24 weeks (- 7 days) or more weeks following the initiation of BDC-1001 • DoR • PFS, Incidence of ADAs against BDC-1001 | — |
Countries
France
Outcome results
None listed